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��Peru© Copyright Lex Mundi Ltd. 2012�� &#x/MCI; 0 ;&#x/MCI; 0 ; &#x/MCI; 1 ;&#x/MCI; 1 ;Counterfeit Medicinal ProductsPERU Estudio Olaechea ��Peru© Copyright Lex Mundi Ltd. 2012�� &#x/MCI; 0 ;&#x/MCI; 0 ;Several raids conducted in the Comercial Center “El Hueco” in down town Lima have been recently conducted by the authorities. Also small raids in formal drugstores that also sell counterfeited medicines have been conducted after some intelligence investigations.Is activity related to counterfeiting a medicinal product a crime? Please state which criminal law provisions may be potentially used against entities engaged in such activity.Yes, counterfeiting of medicinal products is considered a crime in Peru. In April 2011, the section related to crimes against public health of the Peruvian Criminal Code was modified including three new crimes and raising the high end of the penalties predetermined.Themodifications wereconducted in order to have a more specific regulation against medicinal counterfeiting. Previously, some of the actions described below were also considered a crime in Peru under section 288º of the CriminalCode thatsanctioned the commercialization and traffic of noxious products. This section established jail sentences between 2 and 8 years.Together with the modification of the criminal code, the Health Ministry and other institutions are continuously carrying outmedia campaigns informing the public of the dangers of using counterfeited medicinal products. Also the Public Ministry and the police are often conducting raids into both informal and formal markets that commercialize these illegal products and prosecuting the infringers.Regarding the criminal regulations, sections 294A, 294B and 294C of the Criminal Code establish penalties of jail starting at 4 and up to 15 years depending on the action conducted by the infringer and the results of the action. ction 294A sanctions with imprisonment of 4 to 10 years to who falsifies, contaminates or adulteress pharmaceutical products, medical devices or sanitary products or alters their expiration date. The same sentence will be faced by who knowingly imports,commercializes, transports or distributes pharmaceutical products, medical devices or sanitary products in the abovementioned conditions. Section 294B establishes jail sentences from 4 to 8 years for who sells, import or commercializes pharmaceutical products, medical devices or sanitary products after the expiration date has passed and for who stores, transports or distributes with the purpose of commercializing them.Finally Section 294C establishes aggravating situations that will determinate that the infringer of sections 294A and 294B will have to face a jail sentence between 8 to 15 years. ��Peru© Copyright Lex Mundi Ltd. 2012�� &#x/MCI; 0 ;&#x/MCI; 0 ;If as a consequence of the actions described on sections 294A or 294B, serious injuries or death occurs and the agent could have foreseen that as a consequence of his acts, he/she will be facing a jail sentence form 8 to 15 years.The same sentence will be faced by an agent that has the condition of technical director of a pharmaceutical establishment or health establishment and incurs on the actions abovementioned described. Is there a definition of a falsified medicinal product inyour jurisdiction?Law Nº defines pharmaceutical products as“Preparation of known composition, labeling and packaging evenly, intended for use in the prevention, diagnosis, treatment and cure of disease, preservation, maintenance, restoration and rehabilitation of health. In addition this law as well classifies pharmaceutical products as) Medicinal products b) Medicinalherbals,c) Dietetic product and sweeteer d) Biological products e) Galeanic productsHoweverthere is not aspecific definition on our legislation on what is understood by falsified medicinal products. ccording to OMC definition afalsified medicinal product is a product deliberately andfraudently labeled improperly regarding it identity and/or its origin. Both, brand named products and generic medicinal products are suitable to be falsified. Falsified products may include products with the correct or incorrect ingredients, with or without the active principles or with falsified packaging.Please advise on regulations in place to ensure safety of medicinal products and to prevent falsification of medicinal products. Who is authorized to enforce relevant laws?Law Nº 29459 known as thelawof pharmaceuticals, medical devices and health productsdefines and establishesthe principles, norms and basic criteria’s regarding pharmaceuticalproducts devices and health productsfor human useaimed to prevent, diagnose, or for treatment among others. According to this regulation, it even extents to the control of active substances, recipients, and materials used for their manufacture. This law also regulates the actions of the individuals or companiesinvolved in the manufacture, import, export, storage, distribution, marketing, promotion, advertising, prescription, pharmaceutical care, sale, use and final destination of the aforementioned products, as well as the responsibilities and powers of the National Health AuthorityAll products underthe classification of Article 6 of the abovementioned lawrequire authorization.This authorization is the sanitary registrationwhichentitles the holder to manufacture, import, storage, distribution, marketing, promotion, supply, the sale or use of these products. In this sense, any future amendment must also be indicatein such recordsThe health record is temporaryand renewable every five years.The Decree Supreme Nº 016SA also known as the Regulation for Registration, Health Surveillance and Control of Pharmaceuticals, Medical Devices and Health Law Nº 29459, art. Nº 4 inc. 1) ��Peru© Copyright Lex Mundi Ltd. 2012�� &#x/MCI; 0 ;&#x/MCI; 0 ;Products, rules the procedure in order to apply for the sanitary registration according to each medical products classification. The uthority authorized toenforce the abovementioned laws is the General Directorate of Medicines, Supplies and Drugs(DIGEMID)This authority is incharge of sanitary registry as well ain chargeof the Control and surveillanceof anitary authorizations of places which commercialize and manufacture medical products, Control and surveillance of sanitary authorizations for medical products, Control of illegal commerce of medical products and Control of advertisement of medicalproducts.Please advise regarding existing boarder measures (and related legal provisions) allowing regulatory authorities and right holders to fight against counterfeited medicinal products and about the efficiency of such measures.Peruvian legislation on Intellectual Property protects the rights of Copyright and their related rights and trademarks; by Legislative Decree Nº 1092, border measures were approved and aimed to provide greater protection regarding Intellectual roperty rights.The abovementioned legislation of border measures gives the holder of Intellectual roperty rights additional mechanisms to defend their rights against third parties.The main objectives of said rule are the following:(i)Enhance and improve control over the import, export and transit of counterfeited goods (any copy that was made without the consent of the copyright holder) or falsified (any merchandise bearing without authorization a trademark identical or validly registered for such goods);(ii)directly Protecting Copyrights and trademark rights, which it indirectly enable the protection of consumer rights;(iii)Identify, through physical and documentary research conducted by the Customs Authority and INDECOPI possible networks dedicated to counterfeiting of goods. (iv)Remove the large revenue losses related to taxation.The Registry of Intellectual Property rights by the holder must be executed at the National Intendance of Customs Technique (INTA) by filing an application containing the following information:Information identifying the owner of the right: names and last name or trade name; identification document; legal or fiscal domicile, phone number, email address, as it corresponds;Information identifying the applicant as legal representative or proxy: names and last name or trade name, identification document, legal or fiscal domicile, phone number, email address; simple copy of the power or document certifying the representation;Information identifying the right to be registered: specification of the type of right (copyright, related right or trademark right), registration number, certificate, class, as it corresponds; ��Peru© Copyright Lex Mundi Ltd. 2012�� &#x/MCI; 3 ;&#x/MCI; 3 ;o Precise and detailed technical description of the right to be protected attaching documentation, informatics supports and images identifying its features; andTo the extend reasonably available, any other information facilitating Customs the provision of control actions such as, information or data about the type or tendencies of fraud, countries of production; countries of origin, transport paths used, technical differentiation of the authentic and fake products, if applicable. Additional relevant information obtained later by the owner of the right, its proxy or legal representative.Customs will coordinate with the Distinctive Sign Direction or the Copyrights Direction, as it corresponds, to grant the registration or reject it if it does not get a favorable opinion from INDECOPI.et we mention that this registration is annual and must be renewed each year.Finally as positive contributions of this boarder measures can be found as follows:Distinguishes pirate counterfeit goods;It applies to goods in transit Do not stop goods that have no commercial purposes, provided clear evidence to the products entering through customs;Create a registry of holders of intellectual property rights in Customs;Granting of a recognizance bond or equivalent security;Implementation of a system of information exchange between the INDECOPI and Tax Office (SUNAT)To conclude, it is effective inorder to advise or alert the possible entrance of counterfeiting products, in order to initiate the corresponding actions.Are there any regulations allowing manufacturers, distributors or marketing authorization holders to eliminate falsified products from the market? Are there any other legal measures competitors, manufacturers, distributors or marketing authorization holders could take?Other legal measures that can be initiated bymanufacturers,distributors or marketing authorization holders in order to act against falsified products is byfilling claim for trademark infringements or patents infringements against any infringer before the Peruvian Intellectual Property and Trademark Office (INDECOPI)Under this administrative proceeding it is possible to obtain the seizure of the counterfeited products and also, the prohibition of further imports to a entity or subject and depending on the case the destruction of the falsified products.In pharmaceutical market, patents lead to further investigation in order to find cure to diseases as well as in order to found new medical treatments. In Peru the regulation of patents and intellectual property arebasically ruled byDecision 486 of the Andean Communitythe Legislative DecreeNº 1In the case of trademarks and patents protection is given by the registration at the Intellectual Property Office. Also, as part of a criminal prosecution, when a guilty sentence is issued, the products that were seized during the initial stages of the investigation must be destroyed. ��Peru© Copyright Lex Mundi Ltd. 2012�� &#x/MCI; 0 ;&#x/MCI; 0 ; &#x/MCI; 1 ;&#x/MCI; 1 ; &#x/MCI; 2 ;&#x/MCI; 2 ; &#x/MCI; 5 ;&#x/MCI; 5 ;8. Do public authorities or non governmental organizations inform of dangers related to falsified drugs?The General Directorate of Medicines, Supplies and DrugsDIGEMIDthroughhis area of Illegal Commerce, promote different campaignsin orderto informconsumers, and any individual regarding thedangers of falsified drugs as well as how to prevent the acquisition of falsified products. For example: Advisingconsumers, to buy medical products only on authorized pharmacies, hospitals, and to avoid buying medical products in markets, tradeshows or street sellers.Also DIGEMID and the Ministry of Health conduct several press campaigns and publish advices on medical centers and drugstores informing of the risks of consuming counterfeited medicines.Also, there is a group called CONTRAFALMEleaded by the Health Ministry (through the DIGEMID) and formed by several public (such as The National Police, The Customs Office, Trademarks Office, Judicial Power, Public Ministry) and private institutions that works under the parameters of the National Medicinal Politic. The CONTRAFALME was formed to prevent and fight the smuggling,illegal commerce and counterfeit of pharmaceutical products.As part of their activities, the CONTRAFALME also conducts education campaigns related to the dangers of the use of counterfeited drugs.For instance, at the moment, the Consumers Protectionffice(INDECOPI) isadvising inits website, to be aware ofproduct REUMOFAN that has no sanitary registration, this is that the mentioned product has no authorization approved by the General Directorate of Medicines, Supplies and Drugs(DIGEMID). It is possible to get this product by internet for further reference, please check websitehttp://www.indecopi.gob.pe/0/modulos/NOT/NOT_DetallarNoticia.aspx?PFL=0&NOT=48and it can cause severe injuries as unknown secondary effects. Have draft acts implementing 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products forhuman use been already prepared?Not applicable.Does your jurisdiction consider signature and ratification of the Council of Europe Convention on counterfeiting of medical products and similar crimes involving threats to public health?Not applicable.